- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450898
Retrospective Analysis of Acute Pancreatitis After Percutaneous Mechanical Thrombectomy In Treatment Of Thrombotic Disorders
March 3, 2026 updated by: RenJi Hospital
Retrospective Analysis of Acute Pancreatitis After Percutaneous Mechanical Thrombectomy In Treatment Of Thrombotic Disorders (The RATIO Study)
Acute pancreatitis is a rare complication after percutaneous mechanical thrombectomy in treatment of thrombotic disorders.
The objectives of this study include: (1) Determine the incidence and severity of acute pancreatitis after percutaneous mechanical thrombectomy; (2) Identify patient/procedural risk factors; (3) Evaluate clinical outcomes; (4) Develop a diagnosis and treatment pathway.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Percutaneous mechanical thrombectomy (PMT) has seen increasing utilization in the management of acute thrombotic events within both arterial and venous systems.
The rheolytic thrombectomy such as AngioJet system employs hydrodynamic principles to disrupt and remove thrombus.
The efficacy and safety have been demonstrated across various vascular diseases, including deep venous thrombosis (DVT), peripheral arterial occlusions, and dialysis access thrombosis, establishing PMT as a valuable minimally invasive therapeutic option.
Acute pancreatitis is a serious inflammatory condition commonly associated with gallstones, alcohol consumption, hyperlipidemia, or metabolic disorders.
Only isolated case reports have documented this complication following PMT.
Despite the well-documented occurrence of other procedure-related adverse events, such as bradycardia, hemoglobinuria, and renal impairment, pancreatitis remains an exceptionally rare and under-recognized complication.
The objectives of this study include: (1) Determine the incidence and severity of acute pancreatitis after percutaneous mechanical thrombectomy; (2) Identify patient/procedural risk factors; (3) Evaluate clinical outcomes; (4) Develop a diagnosis and treatment pathway.
Study Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qihong Ni
- Phone Number: 15801900772
- Email: niqihong1989@163.com
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200217
- Recruiting
- Renji Hospital
-
Contact:
- Qihong Ni
- Phone Number: 15801900772
- Email: niqihong1989@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with acute pancreatitis after percutaneous mechanical thrombectomy for thrombotic disorders
Description
Inclusion Criteria:
- Patients over 18 years old;
- Patients with thrombotic peripheral vascular diseases treated by percutaneous mechanical thrombectomy;
- Patients developed acute pancreatitis within 14 days after percutaneous mechanical thrombectomy;
- Patients with written informed consent.
Exclusion Criteria:
- Patients with acute pancreatitis attributed to other confirmed causes;
- Patients unable or unwilling to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Acute pancreatitis after percutaneous mechanical thrombectomy group
Patients were diagnosed with acute pancreatitis after percutaneous mechanical thrombectomy in treatment of thrombotic disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of acute pancreatitis
Time Frame: Within 14 days
|
The incidence of acute pancreatitis within 14 days after mechanical thrombectomy for peripheral thromboembolic disease.
|
Within 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of acute severe pancreatitis
Time Frame: Within 14 days
|
The incidence of acute severe pancreatitis within 14 days after mechanical thrombectomy for peripheral thromboembolic disease.
|
Within 14 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Admission to intensive care unit rate
Time Frame: Within 60 days
|
Safety outcomes: Admission to intensive care unit rate within 60 days after mechanical thrombectomy for peripheral thromboembolic disease
|
Within 60 days
|
|
All-cause mortality rate
Time Frame: within 60 days
|
Safety outcomes: All-cause mortality rate within 60 days after mechanical thrombectomy for peripheral thromboembolic disease during hospitalization
|
within 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qihong Ni, Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 5, 2026
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- The RATIO Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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